Pelvic Organ Prolapse, Urinary Stress Incontinence
Conditions
Keywords
Pelvic Organ Prolapse, Urinary stress incontinence, Surgery
Brief summary
It is unknown whether it is best to do the TVT( procedure for urinary stress incontinence in women) at the time of prolapse surgery or at a later date. Women with both conditions were randomized to both procedures together or the TVT 3 months after the prolapse surgery. Any or no leakage when couching was the main end-point, evaluated 1 year after the last surgery
Detailed description
All women were evaluated by the POP-Q (pelvic Organ Prolapse Quantification) prior to surgery and 1 year after. Examination for urinary leakage was done prior to surgery and 1 year after. Group 2 was also examined after prolapse surgery to see if TVT was still needed.
Interventions
PROCEDUREVaginal Repair for prolapse, TVT procedure
1. TVT at the time of Vaginal Repair 2. TVT 3 months after Vaginal Repair
PROCEDURETVT and Prolapse surgery
1. TVT at the time of Prolapse surgery 2. TVT 3 months after Prolapse Surgery
Sponsors
Ullevaal University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
Pelvic Organ Prolapse that needs surgical repair and objectively proven urinary stress incontinence -
Exclusion criteria
Not agreed to participate in randomization \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any or no leakage of urine when coughing | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| The cure of urinary stress incontinence (USI) by only prolapse surgery | 1 year |
| Result of prolapse surgery in two intervention strategies in women suffering from both genital prolapse and USI | 1 year |
Outcome results
None listed